MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. DISPOSABLE DISTAL ATTACHMENT

Model Number D-201-11804

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Hematemesis (4478)

Event Date 06/21/2023

Event Type  Injury  

Manufacturer Narrative

The literature described "d-201-11804, d-201-11304", olympus selected "d-201-11804" as a representative model.The subject device was not returned for evaluation.The literature article is attached for additional information.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

Olympus medical systems corp.(omsc) received a literature titled "technical outcomes and postprocedural courses of mucosal incision-assisted biopsy for possible gastric gastrointestinal stromal tumors: a series of 48 cases(with video)." mucosal incision-assisted biopsy (miab) has been introduced as an alternative to endoscopic ultrasound-guided fine needle aspiration for tissue sampling of subepithelial lesions.However, there have been few reports on miab, and the evidence is lacking, particularly in small lesions.In this case series, we investigated the technical outcomes and postprocedural influences of miab for gastric subepithelial lesions 10 mm or greater in size.Type of adverse events/number of patients: postoperative bleeding (n=1).No intraoperative adverse events occurred, whereas one patient with subepithelial lesion greater than 20mm experienced haematemesis the day after miab.In this case, no bleeding was found on emergency endoscopy, and the patient had no symptoms thereafter without transfusion or hemostatic treatment.This event requires 4 reports.The patient identifiers are as follows: (b)(6) :gif-q260j, (b)(6) : d-201-11804, (b)(6) :fd-410lr, (b)(6) : hx-610-090l.This report is for (b)(6).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial and/or lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, the relationship between the device and the adverse event cannot be confirmed.There was no complaint reported on the subject device.There is no evidence of an olympus device malfunction.Therefore, the root cause cannot be determined.This supplemental report includes a correction to g2 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: DISPOSABLE DISTAL ATTACHMENT
• Type of Device: DISPOSABLE DISTAL ATTACHMENT
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17450105
• MDR Text Key: 320303992
• Report Number: 9614641-2023-01069
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170278280
• UDI-Public: 04953170278280
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K984358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-201-11804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention